The People's Perspective on Medicine

Why Don’t You Trust Generic Drugs as Much as Brand Name Medicines?

What can the FDA do to restore confidence in its oversight of generic drugs?

Why don’t patients and their doctors trust generic drugs? Despite the fact that 84 percent of all prescriptions are dispensed in their generic form, there is still a great deal of skepticism about the quality of these less expensive medications.

Although most people recognize that they can save money on generic drugs, many prefer brand names. In one study, nearly a quarter of the women questioned believed that brand name pills were more effective (Research in Social and Administrative Pharmacy, Nov-Dec, 2012). A different study found that many people perceive generic medicine as less potent and not as good as “the real medicine” (Preventing Chronic Disease, online Aug. 30, 2012).

It is hardly surprising that patients might be reluctant to take medicines they perceive as inferior. What about physicians? A survey of doctors found some startling statistics (Annals of Pharmacotherapy, Jan. 2011). About half said they were concerned about the quality of generic medications. About one fourth responded that they did not like to use generics for themselves or their families. The authors urged the FDA to provide more scientific proof supporting the quality of generics if the agency wants to calm such doubts.

A recent article by FDA officials states that “Patients should have confidence that the generic drugs they are prescribed in the United States can be effectively substituted for the brand product or another generic product” (Clinical Pharmacology & Therapeutics, Oct. 2013). The trouble with this assertion is that the FDA rarely provides any data to support it. The gist of its argument is: trust us; we’re the government and we know what we’re doing.

President Ronald Reagan was fond of quoting a Russian proverb, “Trust but verify.” The FDA says generic drugs are “identical” to their brand name counterparts. The problem is that the feds’ definition of identical doesn’t correspond to the usual understanding of the word.

The agency almost never releases data about generic drug bioequivalence–the rate at which the generic drug gets into the blood stream compared to the brand name. In one unusual instance, however, the FDA did make data public. The drug was Budeprion XL 150, which remains on the market as bioequivalent to Wellbutrin XL 150.

At the end of the first hour, the level of the generic drug was more than 400 percent higher than that of the brand name. After two hours, the generic was three times higher. By six hours into the experiment, the brand name had reached a higher blood level and the generic was dropping rapidly. In other words, the generic drug was absorbed and eliminated much more quickly than the brand name, yet the FDA considers these drugs identical. (See the accompanying graph.)

If the FDA wants the American public to trust generic drugs, there are three steps it must take. The first is transparency. The agency should make data on bioequivalence available for verification. The second is by regular inspections of manufacturing plants both here and abroad. The third is continuous monitoring of generic drug quality by random testing of pills from pharmacy shelves. That way, physicians, pharmacists and patients would have more confidence in generic drugs.

No one wants to pay more for medicine unnecessarily. We offer guidelines for using generic drugs safely in our book, Top Screwups Doctors Make and How to Avoid Them.

 

 

 

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies. .
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All of this comments are 100% right, I moved from my Home State ( Texas ) to Washington State at this State the Providers did prescribed me with Valium 10mg 30mg daily or 1 tablet 3 times a day, but with limited dispense, when at the Military I was prescribed 90 tabs per month and 180 tabs for 2 months 90 x 2=180, but the providers at Washington State I only got 30 tabs that would only last for 10 days. and asked them ” what is it do you want to have me here every 10 days, or what?” I was told by the Government Providers that I have to take this medication for life and the dispense should be the same, then with out letting me know they changed me to the generic ( Diazepam ) I took the prescribed form to the pharmacy and when I took the dose I notice the taste that was not the same, much less was the effect, so at later dates I was diagnosed with High blood pressure, Diabetes, High Cholesterol, so now what, more generics for the treatments of this conditions?

DISCLAIMER: What I state here is only for my personal and Patient experience. I am a VietNam Veteran I had suffered of PTSD Syndrome from the age 11 years, and went untreated all through my Teenage years when I turned to my 18th years I went to register ( mandatory ) to the Selective Service afterward I was called for my physical Exam but PTSD did not revealed, so I was Drafted for Boot Camp and training 2 months in I started to have severe anxiety and Panic attacks and later I was seized with Night mares that I woke up screaming and running that the Military Providers put me on strong jacket and took me in, firstly they injected me with Valium to calm me down then I was followed up with orally Valium Tablets 10mg 1, 3 x daily, immediately I felt the relieve, feelings that I didn’t have since than before reaching my teens. Since the Government started prescribing this medication ( Brand name Valium ) I was much different working with no worries, but I suffered an accident. and that’s another Story; But still say that Brand name Drugs are better than generic, like I said in the beginning of this comment.

The FDA is under pressure by some political hack at a higher level who has the power to influence the FDA. The hack, in turn, is being bought off by some entity who stands to gain from the use of generics. But in the end the FDA is a fraud. It’s not a fraud by the act of commission. It’s a fraud by the act of omission by not requiring every generic drug manufacturer and every insurance company to provide the statement that any generic of any given manufacturer may or may not have the have same effect on some individuals that other generics of other manufacturers or brand may have. Who is paying off the hack? Drug companies, insurance companies or some other entity? I don’t know? All I know is that someone is paying off someone.

Was given generic Travtan-Z in made in India & distributed by an american company. Well, it was burning and drying my eyes more than usual, plus my ocular glaucoma pressure went up 2 points so didn’t work. He then wrote a new Rx for the brand name by signing on the “Dispense as written” on Rx blank and also wrote “medically necessary” so got the brand for $45.00 the same co-pay as generic.

By setting up a ceiling for the cost of medications used by seniors under Medicare, or the Advantage and gap coverage, seniors are forced into using as many generics as possible to try and avoid the donut hole as long as possible. Considering the highly inflated cost of medications in this country, even the generics, many of us fall into the donut hole as early as late spring.
I use one name brand medication, lyrica, whose “price” has gone from $400 in 2010 to almost 700 this year. Additionally, due to doctor errors, I have many other conditions that must be treated with drugs. I pay almost a thousand a year for my lyrica alone and have read the patent has been extended to 2018. I use insulin, a part D medication, and the list price of a vial is somewhere around 150 now. Because of the debacle of 2008, the biggest part of my savings disappeared and my attorney says I was “scammed”, so we are forced to live on SS alone and the least amount I can pull from my other savings as possible. That now is app half of what it was four years ago when I began pulling. I am rapidly approaching the point where I will not be able to afford my medications. Who needs death panels, we have big pharma!

My heart starts to race when I take generics. I know this is true because on the three different times I took prescribed meds I had no idea that they WERE generics so it’s not “all in my head” as doctors love to say. I don’t take generics.

I remember when the FDA could be trusted to protect us but that’s not the case now. Partly, I think the problem was caused by people demanding faster access to drugs used in Europe but not approved for the USA. So the FDA gave in to political pressure and let the bars down. Now we’re reaping what others sowed for us. I never, ever take a generic if I can help it because every pharmacy orders from wherever they can get the best deal, and that can change from month to month. My pharmacist says that the drug part of your pill is the same but with the generics you never know what the fillers are, and they vary from manufacturer to manufacturer so there is no knowledge how good the quality control is — or even if it exists, especially in products of ALL types from China. What a mess!!

I hate taking generics!! I don’t trust them & where they are made!!
Unfortunately I have to take some generics because the cost of a BRAND name is above my senior citizen INCOME budget! I have to take heart medication & a generic is NOT accurate in it’s dosing. Even my cardiologist admitted this!!
Americans must let the FDA & their US Senators & US Representatives know about the inferior quality of a lot of generics made in some remote area of a foreign country!
Big PHARMA is getting by with almost killing US!!

Come on – we have seen enough news reports now about poor quality overseas made generics. I don’t trust them very much at all, except Teva.

Even if the generic is “made” in the US, who knows where the ingredients are made?
If you are given a generic and it was not manufactured in the US, the pharmacy has no way to trace it. Remember the “additives” that were in the dog food from China that killed so many pets a few years ago?
I don’t think we have any idea what we are ingesting. Where is the FDA??? Why aren’t we being protected for this???
MONEY AND PROFIT
What is the profit margin for generics vs brand? Where is the accountablility?

What is your opinion of brand name medications purchased from pharmacies in Canada?

If you have ever worked for a company whose main focus was on selling low-cost products, you know the kinds of shortcuts they take to keep those costs down. This is why I take as few generic drugs as possible. They are not necessarily the same, and they are not necessarily safe.

Remember so many Generics are made in China in remote villages and we have no way of finding out where as they are sold to a distributor in large batches as high as a 100,00 at a time.

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